Lactic Acid, 2-Ethylhexyl Ester; Exemption from the Requirement of a Tolerance, 51623-51628 [05-17360]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Rules and Regulations]
[Pages 51623-51628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17360]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0230; FRL-7729-5]


Lactic Acid, 2-Ethylhexyl Ester; Exemption from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes four exemptions from the 
requirement of a tolerance for residues of lactic acid, 2-ethylhexyl 
ester or ethylhexyl lactate when used as an inert ingredient (solvent) 
in or on growing crops, when applied to raw agricultural commodities 
after harvest, or to animals. Purac America, Inc. submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA), requesting 
an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of lactic acid, 2-ethylhexyl ester.

DATES: This regulation is effective August 31, 2005. Objections and 
requests for hearings must be received on or before October 31, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of theSUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2003-0230. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; e-mail address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at (https://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings athttps://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two athttps://
www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of July 11, 2003 (68 FR 41349) (FRL-7316-
1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 0F6179) by Purac America, Inc., 111 
Barclay Boulevard, Lincolnshire, IL 60069. The petition requested that 
40 CFR 180.950 be amended by establishing an exemption from the 
requirement of a tolerance for residues of the (S) isomer of lactic 
acid, 2-ethylhexyl ester, also known as lactic acid, 2-ethylhexyl 
ester, (2S)- or 2-ethylhexyl lactate (CAS Reg. No. 186817-80-1) when 
used as a solvent, an inert ingredient, in pesticide products. That 
notice included a summary of the petition prepared by the petitioner. 
There were no comments received in response to the notice of filing.
    PURAC's petition requested only the establishment of a tolerance 
exemption for the (S) isomer of lactic acid, 2-ethylhexyl ester. 
However, according to information on the PURAC website, there is also a 
general CAS Reg. No. for lactic acid, 2-ethylhexyl ester (CAS Reg. No. 
6283-86-9). In the simplest terms an isomer can be defined as a 
substance which has the same molecular formula as another, but the 
individual elements of the molecule--the links from one element to 
another within the molecule--are arranged differently. A stereochemical 
isomer differs in the 3-D spatial arrangement of the elements. In 
certain cases, this is sometimes referred to as ``mirror images.'' An 
example of such a mirror image arrangement is a person's right and left 
hand. A person holding his hands out, both palms up, cannot make the 
presentation of four fingers and the thumb of the right hand match the 
orientation of the left hand. They can be viewed as if there is a 
mirror between the two. The chemical and physical properties of two 
isomeric chemicals are essentially the same. There can be some 
differences in the biological properties of the two isomers. The Agency 
has determined that both of the names are appropriate for this chemical 
and is therefore establishing tolerance exemptions using the (S) isomer 
and the general nomenclature of lactic acid, 2-ethylhexyl ester.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA 
defines``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in

[[Page 51624]]

residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children. The nature of the toxic effects caused 
by lactic acid, 2-ethylhexyl ester are discussed in this unit.

A. Acute Toxicity

    The Agency's review of the following two acute toxicity studies and 
the toxicity category classification, are shown in the following Table. 
The Agency uses a scale of I to IV to rate the toxicity of acute 
studies. Toxicity Category I is indicative of very high acute toxicity. 
Toxicity Category IV is the Agency's lowest rating of acute toxicity.

                                             Acute Toxicity Studies
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                Study/Species                             Results                      Toxicity Category
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Acute oral toxicity/rat                       LD50 is equal to or greater                                    III
                                               than 2,000 mg/kg
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Primary eye irritation/rabbit                 Irritating to the eye                                           II
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B. Repeated Dose Inhalation Toxicity Study

    In a 28-day inhalation toxicity study, rats received 6-hour/day 
nose only exposure, for 5 days/week over a 4-week period. The target 
concentrations of lactic acid, 2-ethylhexyl ester were 0 (control), 75, 
200, 600, or 1,800 mg/cubic meter ( mg/m3). A NOEL (no-
observed effect level) was not defined as microscopic effects in the 
respiratory tract were noted even at 75 mg/m3. The Agency's 
reviewer noted that effects seen at 600 mg/m3 (decreased 
absolute spleen weight in males), and 1,800 mg/m3 (gross 
pathology changes of the lungs, significantly decreased body weight in 
males, increases in relative liver weight in both sexes, increases in 
lung weight in males, decreases in absolute spleen weights in both 
sexes, and in relative spleen weight in females) would be more 
consistent with consideration of an adverse effect.

C. Developmental Inhalation Toxicity Study

    Pregnant rats were exposed to lactic acid, 2-ethylhexyl ester at 
target concentrations of 0 (control), 200 or 600 mg/m3 for 6 
hours/day nose only exposure from gestation days 6 to 15. Both the 200 
and 600 mg/m3 concentration groups experienced an increased 
breathing rate. Body weight gains were slightly depressed in both 
groups. There was also a reduced food consumption relative to controls. 
A maternal NOAEL (no observed adverse effect level) was not determined. 
The maternal LOAEL (lowest observed adverse effect level) is 200 mg/
m3.
    Mean fetal body weight values for the 600 mg/m3 group 
were below those of controls. The only effect at 200 mg/m3, 
a slight retardation in fetal ossification, was considered to be 
equivocal and probably secondary to maternal toxicity. The 
developmental NOAEL is 200 mg/m3 and the developmental LOAEL 
is 600 mg/m3 based on reduced mean fetal body weights.

D. Metabolism

    Lactic acid, 2-ethylhexyl ester is formed by combining lactic acid 
and 2-ethylhexanol. In mammalian metabolism, this process is reversed. 
Simple esters such as the lactic acid esters undergo hydrolysis 
yielding lactic acid and the corresponding alcohol. The human body has 
well-understood pathways for metabolizing ingested lactic acid. Humans 
also produce lactic acid as an intermediate product of carbohydrate or 
glucose metabolism. The Food and Drug Administration (FDA) has 
estimated the lactate turnover rate in man to be of the order of 2 
grams/kg/day. The Agency's evaluation of lactic acid has been placed as 
a support document in the EDOCKET for this final rule.
    In the hydrolysis of lactic acid, 2-ethylhexyl ester, the 
corresponding alcohol would be 2-ethylhexanol. The mammalian body would 
metabolize 2-ethylhexanol to the corresponding aldehyde, which would 
then be metabolized to the corresponding carboxylic acid. The mammalian 
body has well-understood pathways for metabolism of carboxylic acids to 
carbon dioxide and water.

E. Toxicity of 2-Ethylhexanol

    Since 2-ethylhexanol (CAS Reg. No. 104-76-7) is the alcohol formed 
via hydrolysis, toxicity studies performed using 2-ethylhexanol as the 
test substance can be used to further understand the toxicity of lactic 
acid, 2-ethylhexyl ester. Three sources of data are available: Data 
submitted to the Agency under a Toxic Substances Control Act (TSCA) 
test rule, the conclusions and recommendations of the Organization for 
Economic Cooperation and Development (OECD), and the International 
Uniform Chemical Information Database (IUCLID) submitted by industry to 
the European

[[Page 51625]]

Chemicals Bureau. Taken together these three data sources supply more 
than adequate information to evaluate the toxicity of 2-ethylhexanol.
    Under a TSCA test rule, toxicity studies performed using 2-
ethylhexanol were submitted to the Agency's Office of Pollution 
Prevention and Toxics (OPPT). Reviews of two carcinogenicity studies 
(mouse and rat) and a dermal developmental toxicity study are posted on 
the Agency's website (see https://www.epa.gov/opptintr/chemtest/
ethylhex.htm). The conclusions of the Agency's reviewers were that 2-
ethylhexanol is not carcinogenic in the mouse under the conditions of 
the study, and that there is no evidence of carcinogenicity in the rat 
at any dose level tested. In the developmental toxicity study there was 
no evidence of developmental toxicity at any dose level. The dermal 
developmental NOAEL is therefore equal to or greater than the highest 
dose tested (HDT), 3.0 milliliter (mL)/kg/day or 2,520 milligram/
kilogram/day (mg/kg/day). Maternal effects (reduced weight gain) were 
noted at the 3.0 mL/kg/day dose level. Exfoliation occurred at the 
application site at the 1.0 mL/kg/day dose level. The maternal NOAEL is 
0.3 mL/kg/day or 252 mg/kg/day.
    The agreed upon conclusions and recommendations of the OECD 
Screening Information Dataset Initial Assessment Profile (SIAP) are 
available via the internet (see https://cs3-hq.oecd.org/scripts/hpv/
Home.asp). The SIAP contains summarized results of OECD's review of 
several 90-day toxicity studies, two carcinogenicity studies, and 
several developmental toxicity studies. The IUCLID for 2-ethylhexanol 
was obtained from the European Chemicals Bureau website (see https://
ecb.jrc.it.esis/). The IUCLID dataset is a compilation of data 
submitted by the manufacturers of 2-ethylhexanol and is posted as 
received. By combining these two sources, the Agency was able to obtain 
more details on certain of the toxicity studies than available in the 
SIAP.
    Results of three 90-day oral toxicity studies are available:
     In a rat feed study, the NOAEL is 57 mg/kg/day and the 
LOAEL is 282 mg/kg/day based on swelling of the liver and kidney.
     In a rat gavage study the NOAEL is 125 mg/kg/day and the 
LOAEL is 250 mg/kg/day based on clinical effects: Cyanide insensitive 
palmitoyl CoA-oxidation in the liver.
     In a mouse gavage study the NOAEL is 125 (male) and 250 
(female) mg/kg/day. The LOAEL is 250(M) and 500(F) based on stomach 
effects.
    These results are consistent (the 57 mg/kg/day is an artifact of 
dose spacing) and indicate that the target organs were the liver, 
stomach, and kidney.
    2-Ethylhexanol was negative in numerous mutagenicity studies. Both 
the SIAP and the IUCLID indicated that 2-ethylhexanol is not 
carcinogenic in the rat or mouse.
    Results of developmental toxicity studies via the oral and 
inhalation routes of exposure performed using 2-ethylhexanol were 
reported in the SIAP and IUCLID.
     For the rat oral (gavage) study the maternal NOAEL is 130 
mg/kg/day and the maternal LOAEL is 650 mg/kg/day. The developmental 
NOAEL is 130 mg/kg/day, and the developmental LOAEL is 650 mg/kg/day 
based on slightly reduced mean fetal body weights and increased 
frequency of fetuses with skeletal variations and retardations.
     In a mouse oral (gavage) developmental toxicity study both 
the maternal and the developmental NOAEL are equal to or greater than 
191 mg/kg/day, the HDT.
     In a single dose rat developmental inhalation toxicity 
study, maternal feed consumption was reduced, but no fetal 
malformations were noted. The maternal NOAEL would be less than or 
equal to 0.850 mg/m3. The developmental LOAEL would be equal 
to or greater than 0.850 mg/m3.
    Metabolism studies performed using 2-ethylhexanol indicate that 
after oral administration, 2-ethylhexanol is rapidly excreted in 
respiratory carbon dioxide, feces, and urine. Elimination is 
essentially complete by 28 hours after administration. Only 3% of the 
administered 2-ethylhexanol is excreted unchanged.
    The SIAP conclusions called for additional testing with the 
metabolite of 2-ethylhexanol, which is 2-ethylhexanoic acid. The 
rationale for this conclusion was based on the results of several oral 
studies conducted at time-frames of less than two weeks duration. The 
IUCLID indicated that these studies were conducted at high dose levels 
ranging from over 300 to 1,500 mg/kg/day. Alterations in testicular 
weights were consistently noted at 1,000 and 1,500 mg/kg/day. 
Alterations in testicular weights were not consistent at dose levels in 
the 300's mg/kg/day. However, the testicular effects were not noted in 
the 90-day oral toxicity studies even at dose levels up to 500 mg/kg/
day.

F. Conclusions

    Acute toxicity studies indicate that lactic acid, 2-ethylhexyl 
ester is of low to moderate acute oral toxicity, and is irritating to 
the eye. The database supplied by the petitioner, most specifically the 
28-day study, indicate that lactic acid, 2-ethylhexyl ester is 
irritating to the lung and respiratory tract. Irritation effects such 
as these are handled through the use of personal protective equipment 
as determined by the end-product acute toxicity testing not through the 
establishment of tolerance exemptions.
    Of significant note for dietary exposure, chemical substances such 
as lactic acid esters hydrolyze in the mammalian body to lactic acid 
and the corresponding alcohol (2-ethylhexanol). The human body has 
well-understood pathways for metabolizing such chemicals. Given the 
relationship of 2-ethylhexanol as a metabolite of the mammalian body's 
metabolism of lactic acid, 2-ethylhexyl ester, data on 2-ethylhexanol 
is useful for understanding the toxicity of lactic acid, 2-ethylhexyl 
ester. Data on 2-ethylhexanol can be used to judge that lactic acid, 2-
ethylhexyl ester is not a carcinogen.
    The Office of Pesticide Programs has reviewed and evaluated a 
developmental inhalation toxicity study conducted with lactic acid, 2-
ethylhexyl ester. OPPT has reviewed and evaluated a dermal 
developmental toxicity study conducted with 2-ethylhexanol. The SIAP 
and IUCLID provided information on another developmental inhalation 
toxicity study conducted with 2-ethylhexanol. None of these studies are 
the route of exposure most appropriate for evaluating dietary exposure; 
however, there are in these studies no indications of any increased 
susceptibility.
    For evaluating dietary exposure the oral developmental and 90-day 
studies conducted using 2-ethylhexanol provide the most appropriate 
information for assessing the toxicity of lactic acid, 2-ethylhexyl 
ester. These studies consistently demonstrate NOAELs greater than 100 
mg/kg/day.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide

[[Page 51626]]

chemical residues under reasonably foreseeable circumstances will pose 
no appreciable risks to human health. In order to determine the risks 
from aggregate exposure to pesticide inert ingredients, the Agency 
considers the toxicity of the inert in conjunction with possible 
exposure to residues of the inert ingredient through food, drinking 
water, and through other exposures that occur as a result of pesticide 
use in residential settings. If EPA is able to determine that a finite 
tolerance is not necessary to ensure that there is a reasonable 
certainty that no harm will result from aggregate exposure to the inert 
ingredient, an exemption from the requirement of a tolerance may be 
established.

A. Dietary Exposure

    1. Food. The Agency has developed a screening-level model for 
predicting dietary exposure to inert ingredients. The results of this 
model are considered to over-estimate exposure to an inert ingredient 
in a pesticide product. The modeled chronic dietary exposure for the 
U.S. population for an inert ingredient is 0.12 mg/kg/day. This is 
well-below the dose levels (discussed above) at which an adverse effect 
is expected from exposure to lactic acid, 2-ethylhexyl ester.
    The Agency must also consider the potential for exposure to lactic 
acid as a result of application of a pesticide product containing a 
lactate ester. Lactic acid occurs naturally in meats, fruits, tomato 
juice, beer, wine, molasses, sour milk, yogurt and cottage cheese. 
Lactic acid has been added to commercially prepared foods since the 
1940-1950s. The FDA has estimated a per capita daily intake for lactic 
acid of 15 mg. Given the existing and wide-spread presence of lactic 
acid in the food supply, the amount of lactic acid that could be 
present as a result of an application of a pesticide product containing 
lactic acid or a lactate ester is expected to be a very small 
proportion.
    2. Drinking water exposure. When released to the environment, 
lactic acid, 2-ethylhexyl ester will be present predominantly in the 
dissolved phase surface and ground water. The chemical is soluble in 
water (0.3 g/liter). Once lactic acid, 2-ethylhexyl is in the water, it 
is expected that at neutral pH degradation would begin immediately via 
hydrolysis. Lactic acid, 2-ethylhexyl ester would also degrade rapidly 
via biodegradation. The estimated half-life of lactic acid, 2-
ethylhexyl ester in soil is 17 days. Based on information submitted by 
the petitioner and estimates from the Agency's PBT profiler (https://
www.pbt.profiler.net) lactic acid, 2-ethylhexyl ester should completely 
degrade to water and carbon dioxide in days. Given the rapid 
biodegradation (i.e. lack of persistance) significant concentrations of 
lactic acid, 2-ethylhexyl ester are very unlikely in either ground or 
surface water used as sources of drinking water.

B. Other Non-Occupational Exposure

    Given their physical/chemical properties, lactate esters could have 
a variety of uses in and around the home. According to information on 
the internet they are being considered as ``green'' replacements for 
many of the organic solvents traditionally used in the manufacturing 
industry.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticide chemicals for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to lactic acid, 
2-ethylhexyl ester. The lactate esters are a structurally-related group 
of chemicals that all hydrolyze to lactic acid, which is not a toxic 
metabolite. For the purposes of this tolerance action, therefore, EPA 
has not assumed that these chemical substances have a common mechanism 
of toxicity with other substances. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at https://www.epa.gov/pesticides/cumulative/.

VII. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the database unless EPA concluded that a different 
margin of safety will be safe for infants and children. Lactic acid, 2-
ethylhexyl ester has been tested in an inhalation developmental 
toxicity study in which there were no indications of increased 
susceptibility. The hydrolysis product of lactic acid, 2-ethylhexyl 
ester is 2-ethylhexanol. Developmental toxicity studies conducted using 
2-ethylhexanol as the test substance have been performed via the oral, 
dermal, and inhalation routes of exposure. The results of these studies 
also do not indicate any increased susceptibility. A safety factor 
analysis has not been used to assess the risk of lactic acid, 2-
ethylhexyl ester. For the same reasons, the additional tenfold safety 
factor for the protection of infants and children is unnecessary.

VIII. Determination of Safety for U.S. Population, and Infants and 
Children

    Based on the available toxicity data on lactic acid, 2-ethylhexyl 
ester and on its metabolites lactic acid and 2-ethylhexanol, EPA 
concludes that there is a reasonable certainty of no harm from 
aggregate exposure to residues of lactic acid, 2-ethylhexyl ester (CAS 
Reg. No. 6283-86-9) and lactic acid, 2-ethylhexyl ester, (2S)- (CAS 
Reg. No. 186817-80-1). EPA finds that establishing exemptions from the 
requirement of a tolerance for lactic acid, 2-ethylhexyl ester (CAS 
Reg. No. 6283-86-9) and lactic acid, 2-ethylhexyl ester, (2S)- (CAS 
Reg. No. 186817-80-1) will be safe for the general population including 
infants and children.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect . . .'' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
lactic acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-9) and lactic 
acid, 2-ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-1) for 
endocrine effects may be required.

B. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

[[Page 51627]]

C. Existing Exemptions

    There are no existing tolerances or tolerance exemptions forlactic 
acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-9) and lactic acid, 2-
ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-1).

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
lactic acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-9) and lactic 
acid, 2-ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-1) nor have any 
CODEX Maximum Residue Levels been established for any food crops at 
this time.

E. List 4B Classification

    It has been determined that lactic acid, 2-ethylhexyl ester (CAS 
Reg. No. 6283-86-9) and lactic acid, 2-ethylhexyl ester, (2S)- (CAS 
Reg. No. 186817-80-1) are to be classified as List 4B inert 
ingredients. This classification is due to the Toxicity Category II 
determination for the acute eye irritation study and the lung 
irritation effects in the 28-day study. Tolerance exemptions for lactic 
acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-9) and lactic acid, 2-
ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-1) are established in 
40 CFR 180.910 and 180.930 instead of 40 CFR 180.950 as requested by 
the petitioner PURAC.

X. Conclusions

    Accordingly, exemptions from the requirement of a tolerance are 
established for lactic acid, 2-ethylhexyl ester (CAS Reg. No. 6283-86-
9) and lactic acid, 2-ethylhexyl ester, (2S)- (CAS Reg. No. 186817-80-
1).

XI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0230 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
31, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2003-0230, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any

[[Page 51628]]

technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of the FFDCA, such as the exemption in this final rule, 
do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism implications 
'' is defined in the Executive order to include regulations that have 
``substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.'' This 
final rule directly regulates growers, food processors, food handlers 
and food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in theFederal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 23, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Lactic acid, 2-ethylhexyl ester   ..................  Solvent
 (CAS Reg. No. 6283-86-9).
Lactic acid, 2-ethylhexyl ester,  ..................  Solvent
 (2S)- (CAS Reg. No. 186817-80-
 1).
                                * * * * *
------------------------------------------------------------------------



0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Lactic acid, 2-ethylhexyl ester   ..................  Solvent
 (CAS Reg. No. 6283-86-9).
Lactic acid, 2-ethylhexyl ester,  ..................  Solvent
 (2S)- (CAS Reg. No. 186817-80-
 1).
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 05-17360 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S